Systems and methods for therapeutic electrical stimulation

ABSTRACT

In various embodiments, the invention disclosed herein provides systems, devices and methods for providing electrical stimulation to a patient. An electrical mechanical interconnection is provided to facilitate user friendly systems and devices. Exemplary therapeutic electrical stimulation devices include a shoe connected mechanically and electrically to a conductor that provides signals for electrical stimulation.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/276,068 filed on Nov. 21, 2008, and entitled “Systems andMethod for Therapeutic Electrical Stimulation” and claims the benefit ofU.S. Provisional Application No. 61/019,489 filed on Jan. 7, 2008entitled “Systems and Method for Therapeutic Electrical Stimulation,”the entirety of which are hereby incorporated by reference.

BACKGROUND

Low-power electrical stimulation has been found to have varioustherapeutic uses. One example of low-power electrical stimulation istranscutaneous electrical nerve stimulation (“TENS”). TENS devicestypically operate by generating low-power electrical impulses that aresupplied to the skin of a patient through electrodes. The electricalimpulses have been found to diminish or completely relieve painpreviously felt by a patient.

There are two primary theories for the effectiveness of TENS devices.The first theory is the Gate Control Theory. In this theory, the mildelectrical stimulation is thought to relieve pain in a similar way aswhen an injured area is manually rubbed. Rubbing acts to mask the painfrom the injury. Similarly, when electrical impulses pass through theskin they pass through portions of the peripheral nervous system. Theelectrical impulses reduce the transmission of pain messages, therebydiminishing or completely relieving pain.

A second theory is the Endorphin Release Theory. This theory states thatthe electrical impulses from the TENS device cause mild to moderatemuscle twitching in the body. The body responds to the muscle twitchingby producing natural pain relievers called endorphins, therebydiminishing or completely relieving the pain.

In addition to TENS, electrical stimulation has also been found to beuseful for other therapies. Examples include edema reduction, woundhealing, iontophoresis drug delivery, muscle stimulation, andinterferential current therapy.

Currently available TENS devices are subject to several drawbacks thatimpair their usability for a patient. For example, some devices arebulky and have many wires that get tangled or in the way of the user.The wiring and bulky housings of some current TENS devices can also beobtrusive and embarrassing for a user to wear in public. In addition,many devices are complex and lack a simple, user-friendly connectionmechanism between controller and electrodes to allow a user to easilyconnect or disconnect the device. The drawbacks of current TENS devicesprevent a user from seamlessly integrating electrical stimulationtherapy into their everyday lives.

SUMMARY

In general terms, this disclosure is directed to therapeutic electricalstimulation and addresses various shortcomings with currently availableelectrical stimulation technologies. In one aspect, the systems, devicesand methods disclosed herein provide improved usability of electricalstimulation devices. Certain embodiments of the present disclosureprovide a therapeutic electrical stimulation device that is userfriendly and easy to wear, comprising a controller for providingelectrical signals for electrical stimulation of the patient and anelectro mechanical intermediate connector arranged to convey theelectrical signals from the controller to the patient. The controllerincludes a power source, an electrical signal generator, and areceptacle, wherein the electrical signal generator is electricallycoupled to the power source, and wherein the electrical signal generatorgenerates electrical signals that are provided to a conductor associatedwith the receptacle. In certain embodiments, the electro mechanicalconnector is an interconnecting patch. An exemplary patch includes ashoe, an insulating layer, and electrodes, wherein the shoe is removablymechanically connected to the controller at the receptacle, the shoe iselectrically coupled to the conductor at the receptacle, and theelectrodes are electrically coupled to the shoe.

Another aspect is a more user friendly controller for a therapeuticelectrical stimulation device, the controller comprising a power sourceincluding a rechargeable battery; an electrical signal generator poweredby the power source and generating an electrical signal, and areceptacle including at least one conductor. The conductor iselectrically coupled to the electrical signal generator to receive theelectrical signal. The receptacle is arranged and configured to receivea portion of an electro mechanical interconnecting patch to electricallycouple a portion of the patch with the conductor.

Yet another aspect is a patch for a therapeutic electrical stimulationdevice, the patch comprising an insulating layer having a first side anda second side; a shoe connected to the first side of the patch andincluding at least two conductors, wherein the shoe is configured forinsertion into a receptacle of a controller of the therapeuticelectrical stimulation device; at least two electrodes adjacent thesecond side of the patch, wherein each conductor is electrically coupledto one of the electrodes; and an adhesive layer connected to the secondside of the insulating layer.

A further aspect is a method of connecting a patch with a controller ofa therapeutic electrical stimulation device, the method comprisingadvancing the controller in a first direction toward that patch toinsert a shoe of the patch into a receptacle of the controller; andadvancing the controller in a second direction to cause the controllerto engage with the shoe.

Another aspect is a method of adjusting the operation of a therapeuticelectrical stimulation device, the method comprising operating thetherapeutic electrical stimulation device in a first mode by executing afirst firmware algorithm; downloading a second firmware algorithm;installing the second firmware algorithm onto the therapeutic electricalstimulation device; and executing the second firmware algorithm tooperate the therapeutic electrical stimulation device in a second mode.

A further aspect is a docking station comprising a housing; a slot inthe housing arranged and configured to receive a therapeutic electricalstimulation device; a power source for supplying power to a therapeuticelectrical stimulation device to recharge a battery; and a datacommunication device for communicating between the therapeuticelectrical stimulation device and a communication network.

In one aspect a system is provided for delivering therapeutic electricalstimulation. The system includes a patient interface component, acontroller component that provides signals for electrical stimulation,and an intermediate electro-mechanical connection component positionedbetween the patient interface component and the controller component.The intermediate component matingly engages with the controllercomponent and includes conducting lines that interface with leads in thecontroller component to provide electrical communication between thepatient interface and the controller component. Each component has auseful life that is determined either, by the device supplier,government regulation, or by natural wear and tear of the componentitself. In certain embodiments, the useful life of the component ispredetermined prior to initial use or sale of the component, and it isreplaced upon expiration of the useful life. In some implementations,the predetermined useful life coincides with a period established byregulatory or other administrative authority by paying for orreimbursing for such component. In some embodiments, such predetermineduseful life is shorter than the period in which the component becomesphysically worn out or inoperable.

In certain embodiments, the patient interface component has a usefullife that is shorter than the useful life of the intermediate component,and the intermediate component has a useful life that is shorter thanthat of the controller component. In certain embodiments, the controllercomponent has a useful life of about five years, the intermediatecomponent is a multiuse component having a useful life of about sixmonths or less, and the interface component is a single use disposable.

In one aspect, the system provides an electro-mechanical interfacebetween the patient and an electro stimulation source. In certainembodiments, the interface has disposable and reusable component. Incertain implementations, the electromechanical interface is formed fromat least two disposable components, with each having a useful life ofdifferent length than that of the other. In some embodiments, the systemprovides a disposable patient contact layer, a disposable/reusableintermediate module, and a reusable controller.

A further aspect is a garment that carries the components and is adaptedto position the patient interface component against the patient.

Yet another aspect is a controller component that has a receptacle witha least one conductor, the conductor is electrically coupled to anelectrical signal generator to receive the electrical signal. Thereceptacle is configured to receive a portion of the intermediatecomponent to electrically couple a portion of the intermediate componentwith the conductor.

In another aspect, the intermediate component is a patch, the patchcomprising a shoe connected to at least one insulating layer andincluding at least one conductor, wherein the shoe is configured forinsertion into the receptacle of the controller component.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key or essentialfeatures of the claimed subject matter, nor is it intended to be used inany way as to limit the scope of the claimed subject matter.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective top view of an example therapeutic electricalstimulation device.

FIG. 2 is a perspective top view of the controller of the therapeuticelectrical stimulation device shown in FIG. 1.

FIG. 3 is a top plan view of the controller of the therapeuticelectrical stimulation device shown in FIG. 1.

FIG. 4 is a front view of the controller of the therapeutic electricalstimulation device shown in FIG. 1.

FIG. 5 is an exploded perspective view of the controller of thetherapeutic electrical stimulation device shown in FIG. 1.

FIG. 6 is a perspective top view of a shoe of the therapeutic electricalstimulation device shown in FIG. 1.

FIG. 7 is a side plan view of a shoe of the therapeutic electricalstimulation device shown in FIG. 1.

FIG. 8A is an exploded perspective view of a shoe of the therapeuticelectrical stimulation device shown in FIG. 1.

FIG. 8B is a front view of a shoe of the therapeutic electricalstimulation device shown in FIG. 1

FIG. 9 is a perspective view of the therapeutic electrical stimulationdevice shown in FIG. 1.

FIG. 10A is a side cross-sectional view of the therapeutic electricalstimulation device before connection.

FIG. 10B is a side cross-sectional view of the therapeutic electricalstimulation device shown in FIG. 9 after connection.

FIG. 11 is a block diagram of an example shoe of the therapeuticelectrical stimulation device shown in FIG. 1 attached to a genericstructure.

FIG. 12 is a perspective top view of another example therapeuticelectrical stimulation device.

FIG. 13 is an exploded perspective view of the therapeutic electricalstimulation device shown in FIG. 12.

FIG. 14 is a right side cross-sectional view of the device shown in FIG.12, including a controller that is disconnected from a patch.

FIG. 15 is a right side cross-sectional view of the device shown in FIG.14 with the controller being arranged over the patch.

FIG. 16 is a right side cross-sectional view of the device shown in FIG.14 with the controller being connected with the patch.

FIG. 17 is a perspective top view of the device shown in FIG. 12 in apartially assembled configuration.

FIG. 18 is a block diagram of an electrical schematic for the controllershown in FIG. 14.

FIG. 19 is an electrical schematic of an exemplary circuit for thecontroller shown in FIG. 14.

FIG. 20 is another block diagram of an electrical schematic for thecontroller shown in FIG. 14.

FIG. 21 is another electrical schematic of an exemplary circuit for thecontroller shown in FIG. 14.

FIG. 22 is a top perspective view of another embodiment of a patch.

FIG. 23A is a schematic illustration of possible applications andconfigurations for the device shown in FIG. 12 and FIG. 1.

FIG. 23B is an exploded perspective view of an exemplary implementationof the devices shown in FIG. 23A.

FIG. 23C is a side cross sectional view of a possible configuration forthe devices shown in FIG. 23A.

FIG. 23D is a perspective view of a possible configuration for thedevices shown in FIG. 23A.

FIG. 24 is a perspective view of an exemplary docking station.

FIG. 25 is a block diagram of an exemplary system for communicatingacross a communication network including the device shown in FIG. 12.

DETAILED DESCRIPTION

Various embodiments will be described in detail with reference to thedrawings, wherein like reference numerals represent like parts andassemblies throughout the several views. Reference to variousembodiments does not limit the scope of the claims attached hereto.Additionally, any examples set forth in this specification are notintended to be limiting and merely set forth some of the many possibleembodiments for the appended claims.

Referring now to FIG. 1, an example therapeutic electrical stimulationdevice 10 is shown. In this example, device 10 is a transcutaneouselectrical nerve stimulation (“TENS”) device. Device 10 includescontroller 11 and an electro-mechanical connecting shoe 13. Controller11 generates electrical impulses and supplies the electrical impulses toshoe 13. The connector shoe 13 receives the electrical impulses fromcontroller 11 and supplies the electrical impulses to a conductive layeror directly to a therapeutic location, such as the skin of a patient.Examples of electrical signals which may be used by controller 11 aredescribed in more detail in U.S. Pat. No. 4,922,908, the teachings ofwhich are incorporated herein by reference.

As shown in FIGS. 2-5, controller 11 includes an outer protective shellformed of upper housing 12 and lower housing 14. Upper and lowerhousings 12, 14 are made of any suitable material such as plastic,metal, or the like. A lower edge of upper housing 12 is configured to beconnected with an upper edge of lower housing 14. In some embodiments, afastener is used to connect upper housing 12 to lower housing 14.Examples of suitable fasteners include adhesive, screws, latchingmechanisms, and other known fasteners. In other embodiments, upperhousing 12 is directly connected to lower housing 14, such as by weldingor over molding.

Upper and lower housings 12, 14 act together to enclose battery 26 andelectrical circuitry 29. As a result, upper and lower housings 12, 14provide protection to the enclosed components from contact with otherobjects that could otherwise damage the components. In some embodiments,upper and lower housings 12, 14 are water resistant to protect enclosedcomponents from water or other fluids. Some embodiments of upper andlower housing 12, 14 are completely sealed to resist most or all fluid,gas, or particle intrusion. Some embodiments are hermetically sealed.

Battery 26 is a power source that provides electrical power tocontroller 11. In some embodiments, battery 26 is a rechargeable batterysuch as a lithium-ion battery. Battery 26 can be charged by connectingcontroller 11 to a battery charger, as described further below. Oneexample of a battery charger is a docking station described in moredetail herein. Inductive charging is used in some embodiments. In otherembodiments, other rechargeable batteries are used, such as a nickelcadmium battery, a nickel metal hydride battery, or a rechargeablealkaline battery. Yet other embodiments include non-rechargeable,disposable batteries, such as alkaline batteries, or other knownbatteries. An alternate embodiment of controller 11 does not includebattery 26, but rather includes a different power source such as acapacitor.

Lower housing 14 includes a controller receptacle 24 that is arrangedand configured to receive a portion 42 of shoe 13. In some embodiments,lower housing 14 and portions of electrical circuitry 28 are uniquelyarranged and configured to mate with portion 42 and resist mating withother shoe configurations. In addition, a railway platform 28 ispositioned within controller receptacle 24 to fit with complementarysurfaces on portion 42 to matingly engage with receptacle 24, asdescribed more fully below. This mating engagement forms a keyedreceptacle. One benefit of a keyed receptacle is that it can be used toresist connection with inappropriate patches or other devices, such asto resist connection with a patch that would be incompatible withcontroller 11. On the other hand, the keyed receptacle is also used insome embodiments to allow connection of controller 11 with various typesof patches or other devices if desired.

In the example shown, the electrical circuitry 28 includes a PCB board29 with a plurality of pins 31 extending therefrom. Pins 31 are sized tobe received in receptacles formed in corresponding portion 42 of theshoe 13 to create an electrical connection between controller 11 andshoe 13, as described below.

Upper housing 12 includes a member 22 that moves into and out ofcontroller receptacle 24 to capture and release corresponding structure42 of the shoe 13. As described further below, as portion 42 is insertedinto controller receptacle 24, and member 22 engages structure 56 onportion 42 to couple portion 42 to controller 11. To release portion 42,the user depresses member 22 to disengage member 22 from portion 56.Portion 42 of shoe 13 can then be pulled out of controller receptacle24.

In one embodiment, controller 11 includes an on-board user interfacehaving a power button 20 and amplitude adjustment buttons 16 and 18.When power button 20 is first depressed, the controller turns ON andbegins generating therapeutic electrical signals. When power button 20is depressed again, the controller turns OFF and stops generating thetherapeutic electrical signals.

While the controller 11 is ON, amplitude adjustment buttons 16 and 18are used to adjust the amplitude of the generated therapeutic electricalsignals accordingly. Amplitude adjustment button 16 provides an input toincrease (“+”) the amplitude of the therapeutic electrical signals.Amplitude adjustment button 18 provides an input to decrease (“−”) theamplitude of the therapeutic electrical signals.

Referring now to FIGS. 6-8B, the shoe 13, with sides 42 a and 42 b, isshown in greater detail. In the example shown, shoe 13 includes upperportion 42 and a base 44, having sides 44 a and 44 b. As shown, upperportion 42 a is mounted to base portion 44 a, and upper portion 442 b ismounted to base portion 44 b. Also typically included, but not shown, isan insulating layer (see, e.g., insulating layer 122 described below).During sliding insertion, portion 42 is configured to engage with areceptacle 24 (shown in FIGS. 9 and 10) of controller 11, as previouslydescribed. Portion 42 is a plastic or other suitable structure used tophysically and electrically connect shoe 13 with controller 11.

The shoe 13 includes two symmetric halves 13 a and 13 b that allowinsertion of an electrical connector 51 inside, as shown in FIG. 8A. Theelectrical connector may be any suitable electrical connection device,such as a FCI connector. The electrical connector 51 fits snugly insideof shoe 13 within the two halves. The electrical connector 51 may befastened inside of the shoe 13 using glue, ultrasonic welding, or otheravailable techniques.

One or more electrodes (such as electrodes 124 and 126 in FIG. 13 orelectrodes 1502 in FIGS. 23B and 23D) are connected to shoe 13. When theelectrodes are applied to a patient, they provide an electricalconnection with the skin of the patient to supply electrical pulses to adesired therapeutic location, such as on the patient's skin. Exemplaryelectrodes are made of one or more sheets of electrically conductivematerial (e.g., conductive polymer or stainless steel). In someembodiments, the electrodes are generally disk-shaped to distribute theelectrical signals across a relatively large area of skin. In otherembodiments, the electrodes are of a variety of other shapes includingring-shaped, circular, elliptical, serpentine, comb-shaped, or otherdesired shape.

In operation, the electrodes are connected to the shoe 13 and ultimatelyto the controller using electrode lead wires 46, 48, which extend fromshoe 13 and connect to the electrical connector 51. The connection oflead wires to the shoe and the electrodes is done using any appropriateconnection mechanism (e.g., metal crimp, solder, etc.).

In certain embodiments, lead wire 46 connects to the shoe 13 throughelectrical connector 51 and to signal pin 31 a in receptacle 50 a. Leadwire 48 connects to the shoe 13 through electrical connector 51 and toground pin 31 b in receptacle 50 b. Lead wire 46 and 48 connect toseparate electrodes no that during stimulation, a voltage potential isgenerated between the electrodes and current enters the skin through oneelectrode, passes through the skin, and then returns through the otherelectrode.

A disposable, conducting adhesive layer (e.g., adhesive layer 128 and1504 described below) is applied to one side of electrodes 124, 126 and1502 to allow the electrodes to be securely, yet removably, adhered tothe skin and to permit the electrical signals to flow from thecontroller 11 to the patient. In some embodiments, adhesive layers 128and 1504 are applied across an entire surface of electrodes 124, 126 and1502. In other embodiments, adhesive layers 128 and 1504 areelectrically connected to the shoe, but not to the regions of electrodes124, 126 and 1502. Other adhesive layer arrangements are used in otherembodiments. Exemplary adhesive layers are made of an electricallyconductive material such as an electrogel or hydrogel (e.g., UltraStimSelf-Adhering Neurostimulation Electrodes made by AxelgaardManufacturing Co.). The adhesive layer is preferably disposed of afterone use, but may reused for multiple applications. Some embodiments ofshoe 13 include additional layers.

During stimulation, controller 11 generates a voltage potential betweenelectrode lead wires 46, 48 such that the current enters the skinthrough one wire, passes through the skin, and then returns through theother wire. Some embodiments provide a plurality of electrodes. In someimplementations, the polarity of the electrodes is alternated during atherapy. In some embodiments a skin preparation product, such as aconductive gel, is applied to the skin prior to application of shoe 13.

To make electrical connection between shoe 13 and controller 11, portion42 includes a plurality of receptacles 50 a-50 c on a front face 52 ofportion 42. The receptacles are part of connector 51 (e.g., FCIconnector) housed inside of shoe 13. The three electrical receptacles 50a-50 c are assigned various functions such as providing an electricalsignal, connection to ground, and battery charging connection. Theelectrical receptacles 50 a-50 c are sized to receive pins 31 a-31 c,respectively, of controller 11 when portion 42 is fully inserted intoconnector receptacle 24 (see FIGS. 9 and 10), and provide a locationwhere the pins 31 a and 31 b connect with the lead wires 46 and 48,respectively. As shown, pins 31 extend generally parallel to the railwayplatform 28.

Fitting pins 31 into receptacles 50 creates an electrical connectionbetween controller 11 and shoe 13 and allows controller 11 to deliverelectrical stimulation therapy through electrode lines 46, 48 to thepatient. In particular, as shown, receptacle 50 a receives theelectrical signal pin 31 a and receptacle 50 b receives the ground pin31 b, which combine to form the electrical connection between the shoe13 and the controller 11. Receptacle 50 c receives the battery chargingpin 31 c. It will be appreciated that when the shoe 13 and thecontroller 11 are mated together for operation, the battery charging pin31 c sits within the receptacle 50 c but does not electrically connect.As discussed below, the controller 11 may be disengaged from the shoe 13after patient therapy and connected to a battery charging station.

The mechanical connection between the shoe 13 and controller 11 isfurther shown in FIGS. 6-10B. With reference to FIG. 6, shoe 13 includesportion 42 that defines a channel 54 sized to receive railway platform28 of controller 11 when portion 42 is inserted into controllerreceptacle 24. Railway platform 28 slides inside channel 54 belowportion 42 and above the bottom surface defining channel 54, fitting ina ‘U’ shape around portion 55 of shoe 13. Also, portion 42 includes aclip member 56 sized to engage a detent or lip 23 of member 22 ofcontroller 11 when portion 42 is fully inserted into controllerreceptacle 24 to retain portion 42 within receptacle 24. In certainembodiments, when clip member 56 engages the lip 23 of member 22 theconnection creates an affirmative “click” sound, indicating that shoe 13is connected to controller 11. In addition, the base 44 of the shoeincludes two side flanges 44 a and 44 b. As the shoe 13 slides intoconnection with the controller 11, the base flanges 44 a and 44 b slideunder and at least partially abut respective side portions 8 a and 8 bof the controller 11.

Referring now to FIGS. 9 and 10B, the coupling between shoe 13 andcontroller 11 also occurs as pins 31 of controller 11 are inserted intoreceptacles 50 of portion 42 of shoe 13.

The process of connecting shoe 13 and controller 11 begins as shown inFIG. 10A which depicts the controller 11 and shoe 13 detached and inposition to be coupled. By moving shoe 13 in the direction X (i.e., inthe direction of the arrow toward controller 11), they can be coupled asshown in FIGS. 9 and 10B.

When coupled, railway 28 of controller 11 is received in channel 54 ofportion 42 and allows portion 42 to be slid along railway 28 as portion42 is inserted into controller receptacle 24. Additionally, railway 28fits around portion 55 of shoe 13. The engagement of railway 28 andchannel 54 fixes the position of controller 11 and shoe 13 in adirection Y so that shoe 13 cannot be moved out of controller receptacle24 in the direction Y.

Further, lip 23 of member 22 of controller 11 is engaged by clip member56 of portion 42. The engagement of lip 23 and clip member 56 fixes theposition of controller 11 and shoe 13 in a second dimension so that shoe13 cannot be moved in a direction X out of controller receptacle 24.When the user wants to remove portion 42 from controller receptacle 24,the user depresses member 22 in the direction Y so that lip 23 clearsclip member 56. Portion 42 thereupon be slid along railway 28 indirection X out of receptacle 24. Flanges 44 a and 44 b engage portions8 a and 8 b, as described above.

Other configurations can be used to maintain the portion 42 in thereceptacle 24. For example, in another embodiment, a knob or knurl canbe formed on the portion 42 that engages or is seated with a detentwithin the receptacle when fully inserted. When the portion 42 isremoved, the knob or knurl flexes slightly to bend away from the detentso that the portion can be removed. Other configurations are possible.

In some examples described herein, shoe 13 is connected to a garment todeliver therapy to the user. The is made by stitching, gluing orembedding the shoe 13 in a laminate layer. In other examples, shoe 13 isconnected to other structures to deliver therapy; charge controller 11;and/or program controller 11.

For example, referring now to FIG. 11, shoe 13 is electrically connectedto a structure 60. As described below, shoe 13 can be connected to aplurality of different structures so that controller 11 can be coupledthereto.

In some examples, structure 60 is an apparatus that can be used todeliver therapy to the user. For example, as described below, structure60 can be a patch (e.g., patch 104) or an electrode that is attached tothe skin to deliver therapy. In other examples, structure 60 is agarment such as a belt that is worn around certain anatomy of a patient,such as the waist, arm, or leg. One or more shoes 13 can be locatedalong the belt so that one or more controllers 11 can be coupled to theshoes 13 to deliver therapy at desired locations along the belt. Forexample, the belt can include a single shoe 13 for one controller 11,and can include a plurality of electrodes that are spaced along the beltto deliver therapy along an entire surface for the patient. FIG. 23Dshows an example of a belt including a shoe 13 with base 44 electricallyconnected to electrodes 1502. Electrodes 1502 may be placed in anyposition along the belt and in any pattern suitable to provide therapyto a user. There may be an array of four electrodes, as shown in FIG.23D, or there may be more or fewer electrodes provided as necessary. Inaddition, multiple shoes 13, may be placed on the belt of FIG. 23D. Inother examples, structure 60 is a brace or cast (e.g., air cast, kneebrace, or back brace) with built-in electrodes that allow controller 11to be connected to the shoe and delivery therapy to the desired area.

In some embodiments, structure 60 is electrical components that are usedto provide power so that controller 11 can be connected to shoe 13 tocharge battery 26 in controller 11. For example, in one embodiment,structure 60 is a docking station, such as docking station 1300described below. In other examples, structure 60 is an electrical powertransformer that can be plugged into a typical wall outlet or anautomobile outlet to provide power to charge battery 26. In otherexamples, controller 11 can also include an auxiliary charging port,such as a USB or micro-USB port, which can be used to charge controller11. In yet other examples, controller 11 can include on-board rechargecapabilities, such as solar panels or inductive coupling technologies.

In yet other examples, structure 60 is electrical circuitry that can beused to program controller 11. In some embodiments, controller 11includes computer readable media, such as RAM or ROM. In one embodiment,controller 11 includes flash memory that can be rewritten with newtherapy programs to enhance the functionality of controller 11.

In such examples, structure 60 can be a docking station, such as dockingstation 1300 described below. In other examples, structure 60 can be acomponent in a care giver's office that allows the care giver to modifyor enhance the therapies that can be provided by controller 11. In otherexamples structure 60 can be connected to a LAN or have an Internet orphone connection.

Referring now to FIG. 12, another example therapeutic electricalstimulation device 100 is shown. Device 100 is similar to device 10described above, except that device 100 is configured differently. Inthe example of FIG. 12, device 100 is a transcutaneous electrical nervestimulation (“TENS”) device. Device 100 includes controller 102 andpatch 104, similar to those described above. Controller 102 is a devicethat generates electrical impulses and supplies the electrical impulsesto patch 104. Patch 104 receives the electrical impulses from controller102 and supplies the electrical impulses to a therapeutic location, suchas the skin of a patient.

In one embodiment, controller 102 includes a user interface having apower button 110 and amplitude adjustment buttons 112 and 114. Whenpower button 110 is first depressed, the controller turns ON and beginsgenerating therapeutic electrical signals. When power button 110 isdepressed again, the controller turns OFF and stops generating thetherapeutic electrical signals.

While the controller 102 is ON, amplitude adjustment buttons 112 and 114are used to adjust the amplitude of the generated therapeutic electricalsignals accordingly. Amplitude adjustment button 112 provides an inputto increase the amplitude of the therapeutic electrical signals.Amplitude adjustment button 114 provides an input to decrease theamplitude of the therapeutic electrical signals.

Patch 104 is typically applied to the skin of a patient. The electricalsignals are conducted from the controller to the skin by patch 104.Patch 104 includes a shoe 120 (shown in FIG. 13), an insulating layer122, and conductive electrodes 124 and 126. Shoe 120 is connected to oneside of insulating layer 122, and is configured to engage with areceptacle (shown in FIG. 14) of controller 102. Shoe 120 is a connectorused to physically and electrically connect patch 104 with controller102.

Electrodes 124 and 126 (shown more clearly in FIG. 13) are locatedadjacent insulating layer 122 on a side opposite shoe 120. Theelectrodes are typically a sheet of electrically conductive materialthat, when applied to a patient, provides an electrical connection withthe skin of the patient to supply electrical pulses to a desiredtherapeutic location. An adhesive layer 128 is typically applied to oneside of patch 104 to allow patch 104 to be securely, yet removably,adhered to the skin. Some embodiments of patch 104 include additionallayers.

During stimulation, controller 102 typically generates a voltagepotential between electrodes 124 and 126 such that current enters theskin through one electrode, passes through the skin, and then returnsthrough the other electrode. Some embodiments alternate the polarity ofthe electrodes during a therapy. In some embodiments a skin preparationproduct, such as a conductive gel, is applied to the skin prior toapplication of patch 104.

In some embodiments, buttons 110, 112, and 114 are arranged with aunique tactile arrangement. For example, buttons 110, 112, and 114 arearranged at one end of controller 102 and protrude out from the housingof controller 102. The tactile arrangement allows the device to becontrolled by the patient or caregiver even if the device is hidden fromview under clothing or in a non-visible location, such as on the back.If, for example, the device is located under a shirt on the patient'supper arm, the patient can feel controller 102 through the shirt andlocate protruding buttons 110, 112, and 114. Due to the uniquearrangement of buttons 110, 112, and 114, the user is able to identifyeach button, and select from them accordingly. Other embodiments includeadditional tactile elements. For example, in some embodiments buttons110, 112, and 114 include an elevated identifier, such as a line,square, arrow, dot, circle, or Braille character. In other embodiments,buttons 110, 112, and 114 each include a unique shape, such as a square,triangle, circle, oval, rectangle, arrow, or other desired shape. In yetother embodiments, buttons are located on different locations of thehousing, such as on the sides or bottom of the housing.

FIG. 13 is an exploded perspective view exemplary therapeutic electricalstimulation device 100. Device 100 includes controller 102 and patch104. Controller 102 includes upper housing 202, battery 204, user inputdevices 206, electrical circuitry 208, and lower housing 210. Patch 104includes shoe 120, insulating layer 212, electrodes 124 and 126, andadhesive layer 128.

Controller 102 includes an outer protective shell formed of upperhousing 202 and lower housing 210. Upper and lower housings 202 and 210are made of any suitable material such as plastic, metal, or the like. Alower edge of upper housing 202 is configured to be connected with anupper edge of lower housing 210. In some embodiments, a fastener is usedto connect upper housing 202 to lower housing 210. Examples of suitablefasteners include adhesive, screws, latching mechanisms, and other knownfasteners. In other embodiments, upper housing 202 is directly connectedto lower housing 210, such as by welding or over molding.

Upper and lower housings 202 and 210 act together to enclose battery 204and electrical circuitry 208 and to at least partially enclose userinput devices 206. As a result, upper and lower housings 202 and 210provide protection to the enclosed components from contact with otherobjects that could otherwise damage the components. In some embodiments,upper and lower housings 202 and 210 are water resistant to protectenclosed components from water or other fluids. Some embodiments ofupper and lower housing 202 and 210 are completely sealed to resist mostor all fluid, gas, or particle intrusion. Some embodiments arehermetically sealed.

Lower housing 210 includes a controller receptacle 211 that is arrangedand configured to receive shoe 120 of patch 104. In some embodiments,lower housing 210 and portions of electrical circuitry 208 are uniquelyarranged and configured to mate with shoe 120 and resist mating withother shoe configurations. This is sometimes referred to as a keyedreceptacle. One benefit of a keyed receptacle is that it can be used toresist connection with inappropriate patches or other devices, such asto resist connection with a patch that would be incompatible withcontroller 102. On the other hand, the keyed receptacle is also used insome embodiments to allow connection of controller 102 with varioustypes of patches or other devices if desired.

Battery 204 is a power source that provides electrical power tocontroller 102. In some embodiments, battery 204 is a rechargeablebattery such as a lithium-ion battery. Battery 204 can be charged byconnecting controller 102 to a battery charger. One example of a batterycharger is a docking station described in more detail herein. Inductivecharging is used in some embodiments. In other embodiments, otherrechargeable batteries are used, such as a nickel cadmium battery, anickel metal hydride battery, or a rechargeable alkaline battery. Yetother embodiments include non-rechargeable, disposable batteries, suchas alkaline batteries, or other known batteries. An alternate embodimentof controller 102 does not include battery 204, but rather includes adifferent power source such as a capacitor.

User input devices 206 receive input from a user to cause controller 102to adjust an operational mode of the device 100. Different operationalmodes may be used to provide different types of therapy, such as therapyto treat edema or to provide drug delivery. A more thorough descriptionof how operational modes work can be found in U.S. Pat. No. 5,961,542which is incorporated herein by reference. User input devices 206include power button 110 and amplitude adjustment buttons 112 and 114.User input devices 206 are arranged such that a portion of buttons 110,112, and 114 protrude through upper housing 202. A user provides inputto controller 102 by momentarily depressing one of buttons 110, 112, and114. When the button is depressed, the force is transferred through userinput device 206 to a switch of electrical circuitry 208. The switchcloses to make an electrical connection and causes current flow withinelectrical circuitry 208. The electrical circuitry 208 responds toadjust the appropriate operational mode of controller 102.

Electrical circuitry 208 typically includes a circuit board and aplurality of electrical circuits such as a power supply circuit, pulsegenerator circuit, and electrical contacts for electrical connectionwith conductors of shoe 120. Examples of electrical circuitry 208 aredescribed in more detail herein. In some embodiments, electricalcircuitry 208 includes sensors that receive electrical signals frompatch 104. In some embodiments the electrical circuitry is activatedbetween output pulses to monitor the patient. Some embodiments ofcontroller 102 further include sensor electronics that monitor patch 104to be sure that patch has not become partially or fully disconnectedfrom the patient. If the patch does become disconnected, the electronicsdeactivate delivery of therapeutic electrical signals from controller102. A more detailed description of how a patch connection can bemonitored is found in U.S. Patent Application Publication No.2004/0015212, which is incorporated herein by reference. In someembodiments, the electronics monitor for changes in impedance betweenelectrodes. In another embodiment, electrical circuitry 208 alsoincludes activity monitoring, such as with an accelerometer. Withactivity monitoring, feedback control is used to increase electricalstimulation level in response to activity level.

Patch 104 is a device that transfers electrical impulses from controller102 to a therapeutic location on a patient, such as the patient's skin.Patch 104 includes shoe 120, insulating layer 212, electrodes 124 and126, and adhesive layer 128.

Shoe 120 is arranged and configured to engage with controller 102, suchas through controller receptacle 211. In some embodiments, shoe 120includes a unique configuration that is designed to mate only withcontroller receptacle 211 and to resist connection with otherreceptacles or devices. The unique configuration is sometimes referredto as a keyed shoe. One benefit of a keyed shoe is that it can be usedto resist connection with inappropriate controllers or other devices,such as to resist connection with a controller that would beincompatible with patch 104. This may be done by creating a unique shoeconfiguration with a particular two or three dimensional shape that fitssnugly within controller receptacle 211. Thus, controller receptaclesand shoes that do not have a matching two or three dimensional shapecannot be connected. On the other hand, the keyed shoe is also used insome embodiments to allow patch 104 to be connected with various typesof controller 102. In this case, the shoe may be designed with a two orthree dimensional shape that fits into multiple controller receptacles.Shoe 120 includes conductors that conduct electrical signals betweencontroller 102 and electrodes 124 and 126.

Patch 104 includes insulating layer 212. Insulating layer 212 isconnected to patch 104 by any suitable fastening mechanism, such asadhesive, screws, nails, or other known fasteners. In other embodiments,insulating layer 212 and shoe 120 are formed of a unitary piece, such asby molding. Conductors from shoe 120 pass from shoe 120, throughinsulating layer 212, and are connected to electrodes 124 and 126.

In some embodiments, insulating layer 212 is a primary structural layerof patch 104. Insulating layer 212 also electrically insulates a side ofpatch 104. In this way, if insulating layer 212 comes into contact witha conductive object (e.g., the hand of the patient or another electronicdevice), insulating layer 212 prevents or at least resists theelectrical conduction between electrodes 124 and 126 and the conductiveobject. Inadvertent electrical shocks and unintended electricalconnections are thereby reduced or entirely prevented.

Electrodes 124 and 126 are electrical conductors that are used tointroduce electrical signals to a therapeutic location of a patient,such as on to the patient's skin. Electrodes 124 and 126 areelectrically connected to conductors that pass through shoe 120. In someembodiments electrodes 124 and 126 are generally disk-shaped todistribute the electrical signals across a relatively large area ofskin. In other embodiments, electrodes 124 and 126 are of a variety ofother shapes including ring-shaped, circular, elliptical, serpentine,comb-shaped, or other desired shape.

Patch 104 is connected to the skin of a patient with adhesive layer 128.In some embodiments, adhesive layer 128 is applied across an entiresurface of patch 104, including across electrodes 124 and 126. In suchembodiments, adhesive layer 128 is electrically conductive. In otherembodiments, adhesive layer 128 is applied to the surface of patch 104,but not on the regions of electrodes 124 and 126. Other adhesive layerarrangements are used in other embodiments.

FIGS. 14-16 illustrate an exemplary method of connecting a controller102 to a patch 104 of a therapeutic electrical stimulation device 100.FIGS. 14-16 are right side cross-sectional views of device 100. FIG. 14illustrates controller 102 disconnected from patch 104. FIG. 15illustrates controller 102 arranged in a first position over patch 104.FIG. 16 illustrates controller 102 arranged in a second position andconnected with patch 104. A method of disconnecting controller 102 frompatch 104 is the reverse of that described herein.

Before connecting controller 102 with patch 104, patch 104 is typicallyapplied to a desired therapeutic location on the patient (not shown inFIG. 14) such that shoe 120 extends from patch 104 in a directiongenerally away from the therapeutic location.

The process of connecting controller 102 with patch 104 begins asillustrated in FIG. 14, such that controller 102 is arranged such thatcontroller receptacle 211 is in line with shoe 120. Controller 102 isalso oriented such that rear side 301 of shoe 120 is facing toward therear side 302 of receptacle 211. In some embodiments, shoe 120 inreceptacle 211 is shaped such that shoe 120 can only be inserted intoreceptacle 211 in a single orientation. In other embodiments, shoe 120can be inserted within receptacle 211 in multiple orientations, but canonly be fully engaged (as shown in FIG. 16) if shoe 120 and receptacle211 are properly oriented.

Once properly oriented, controller 102 is moved toward patch 104 in thedirection of arrow A1, such that shoe 120 enters receptacle 211 as shownin FIG. 15. Controller 102 is then advanced in the direction of arrowA2. This movement of controller 102 causes shoe 120 to engage withcontroller 102 as shown in FIG. 16. In particular, electrical circuitry208 makes electrical contact with conductors of shoe 120 to electricallyconnect electrodes of patch 104 with electrical circuitry 208.

Electrical connectors are used to electrically connect conductors ofshoe 120 with electrical circuitry 208. In one embodiment, male andfemale plug-type connectors are included as part of shoe 120 andelectrical circuitry 208. In another embodiment, surface conductors areused to connect with protruding electrical contacts, such as used inUniversal Serial Bus (USB) connectors and for connecting memory cardswith memory slots. Other electrical connectors are used in otherembodiments.

As described above, FIGS. 14-16 illustrate a two-step method ofconnecting patch 104 and controller 102. The first step involves movingcontroller 102 in the direction of arrow A1, and the second stepinvolves moving controller 102 in the direction of arrow A2. This methodof connection is partially a result of the “L-shape” of shoe 120. Shoe120 has a first portion 304 that extends generally normal to a surfaceof insulating layer 212, and a second portion 306 that extends atgenerally a right-angle to the first portion 304.

One of the benefits of this shape of shoe 120 is that it resistsunintentional disengagement of controller 102 from patch 104, oncecontroller 102 is properly connected (as shown in FIG. 16). For example,if a force is applied to controller 102 in a direction opposite arrowA1, the second portion of shoe 120 resists disengagement of controller102 from patch 104. Sideways forces (e.g., forces normal to arrow A1 andarrow A2) are also resisted, as well as a force in the direction ofarrow A2. A force in the direction opposite arrow A2 will result indisconnection of shoe 120 from electrical circuitry 208. However, shoe120 will still provide support to receptacle 211 unless controller 102is arranged vertically below patch 104. This allows the user to manuallygrasp controller 102 before it becomes completely disconnected frompatch 120 and reconnect controller 102, if desired. If controller 102 isarranged vertically below patch 104, then gravity will tend to pullcontroller 102 away from patch 104.

In another embodiment, shoe 120 has a generally linear shape (not shownin FIGS. 14-16), such that shoe 120 is plugged directly into controller102 in a single step, namely the insertion of shoe 120 into receptacle211. In this embodiment, electrical circuitry 208 includes an electricalconnector that is in line with the path of entry of shoe 120 intoreceptacle 211 or directly surrounds the point of entry.

In another possible embodiment, shoe 120 has an “L-shape” but receptacle211 is arranged on a side of controller 102. In this embodiment,connection of controller 102 with patch 104 is accomplished in a singlestep—insertion of a second portion of shoe 104 into the side receptacle.

Some embodiments of shoe 120 and receptacle 211 are arranged andconfigured to safely disconnect from each other upon the application ofa sufficient force. If the user bumps device 100 on another object, forexample, it is preferred that controller 102 electrically disconnectsfrom patch 104 before patch 104 becomes disengaged from the patient.Shoe 120 and receptacle 211 are designed to remain connected unless asufficient force is applied to controller 102 and before the forcebecomes large enough to disconnect patch 104 from the patient.

FIG. 17 is a perspective top view of an exemplary embodiment ofpartially assembled device 100. In this figure, upper housing 202 andbattery 204 (shown in FIG. 13) are removed. Device 100 includescontroller 102 and patch 104. Controller 102 includes user input device206 and electrical circuitry 208. Electrical circuitry 208 includescircuit board 602 and electronic components 604. Electrical components604 include transformer 606, status indicator 608, and electricalconnector 610.

In FIG. 17, shoe 120 is shown in the fully connected position, such asshown in FIG. 16. When in this position, electrical connectors of shoe120 mate with electrical connectors 610 of electrical circuitry 208.Circuit board traces on or within circuit board 602 communicateelectrical signals between electrical components 604 and shoe 120.

Some embodiments of electrical circuitry 208 include transformer 606. Insome embodiments (such as shown in FIG. 13), the transformer is mountedon a surface of the circuit board. To reduce space consumed bytransformer 606, some embodiments include a hole in circuit board 602.Transformer 606 is inserted within the hole to reduce the overalldistance that transformer 606 extends above circuit board 602. Thisallows upper and lower housing 202 and 210 to have a reduced profile.Some embodiments include a receptacle in the circuit board (e.g.,circuit board 29 of FIG. 5) to accept a component such as portion 42 ofshoe 13. This allows the allows pins 31 of circuit board 29 to extendinto the space created by connector receptacle 24.

Some embodiments include one or more status indicators 608. Statusindicators inform a user of the operational status of device 100 and cancome in the form of visual, audible, and/or tactile indicators. Examplesof suitable status indicators 608 include a light, an LED, a liquidcrystal or other type of display, a speaker, a buzzer, and a vibrator.Status indicators 608 are used in some embodiments to show whetherdevice 100 is ON or OFF. In other embodiments, status indicators 608communicate an operational mode, such as a type of therapy beingprovided, or a change in operational mode, such as an increase ordecrease in amplitude. In yet other embodiments, status indicators 608are used to show battery power status (e.g., full power, percentage offull power, or low on power/in need of charge), or charging status(e.g., charging or fully charged). Other indicators are used in otherpossible embodiments. Speakers, buzzers, and vibrators are particularlyuseful for those with certain disabilities or impairments and also forcommunication when the device is located in an area that is not easilyvisible (e.g., on the back of a patient).

FIG. 18 is a block diagram of an exemplary electrical schematic forcontroller 102. Controller 102 includes power supply 700, pulsegenerator 702, power switch 704, amplitude adjustment switches 706, andoutput 708.

Power supply 700 provides electrical power to controller 102. In someembodiments, power supply 700 includes a battery and also includes powerfiltering and/or voltage adjustment circuitry. Power supply 700 iselectrically coupled to power switch 704 and to pulse generator 702.Power switch 704 receives input from a user through power button 110(e.g., shown in FIG. 12) and operates with power supply 700 to turncontroller 102 ON or OFF.

Pulse generator 702 generates therapeutic electrical signals. Pulsegenerator 702 is electrically coupled to output 708 and provides theelectrical signals to output 708. In turn, output 708 is electricallycoupled to patch electrodes to deliver the electrical signals to thetherapeutic location of the patient. Amplitude adjustment switches 706are electrically coupled to pulse generator 702 and receive input fromthe user through amplitude adjustment buttons 112 and 114 (e.g., shownin FIG. 12). Amplitude adjustment switches 706 operate with pulsegenerator 702 to adjust the intensity of the electrical signals sent tooutput 708.

Some examples of suitable pulse generators are described in U.S. Pat.Nos. 4,887,603 and 4,922,908, both by Morawetz et al. and titled MEDICALSTIMULATOR WITH STIMULATION SIGNAL CHARACTERISTICS MODULATED AS AFUNCTION OF STIMULATION SIGNAL FREQUENCY, the disclosure of which ishereby incorporated by reference in its entirety. In some embodiments,the electrical signals generated by pulse generator 702 are simplemodulated pulse (SMP) signals. Other configurations and electricalsignals are possible.

FIG. 19 is an electrical schematic of an exemplary circuit forcontroller 102. Controller 102 includes power supply 800, pulsegenerator 802, power switch 804, amplitude adjustment switch 806, andoutput 808. Power supply 800 includes battery 812, thermistor 814, stepup converter 816, and other electrical components. Power supply 800 iselectrically coupled to supply power to pulse generator 802. Inaddition, power supply 804 is electrically coupled to connector block820 that is used to supply power to power supply 800 to charge battery812.

In this example, battery 812 is a lithium-ion battery having a voltageof about 3.7 to 4.2 volts, although other battery types and voltages areused in other embodiments. Thermistor 814 is electrically coupledbetween battery 812 and connector block 820 and is used to detect thetemperature of battery 812 to ensure that battery 812 is not overheatedwhile recharging. Power switch 804 is used to turn controller 102 ON orOFF. Power switch 804 may be easily controlled, for example, by usercontrol 110. In one embodiment, switch 804 is a single pole double throw(SPDT) switch, as shown. Power supply 800 also includes step upconverter 816. Step up converter 816 operates to increase the voltage ofpower from battery 812 to a desired voltage. One suitable step upconverter is the LTC3401 micropower synchronous boost converter that isdistributed by Linear Technology Corporation, with headquarters inMilpitas, Calif.

Pulse generator 802 receives power from power supply 700 and generates atherapeutic electrical signal. The therapeutic electrical signal isprovided by pulse generator 802 to output 808. Pulse generator 802includes amplitude adjustment switch 806. Amplitude adjustment switch806 may be easily controlled, for example, by user controls 112 and 114.In this embodiment, amplitude adjustment switch 806 is a potentiometer.When the potentiometer is adjusted, intensity of the electrical signalgenerated by pulse generator 802 is increased or decreased accordingly.

In this example, pulse generator 802 includes first and second timers830 and 832 as well as additional circuitry as shown. In one embodiment,both timers 830 and 832 are the TS556 low-power dual CMOS timer,distributed by STMicroelectronics, with headquarters in Geneva,Switzerland.

Pulse generator 802 also includes output stage 840. Output stage 840includes MOSFET 842 and transformer 844. Output stage 840 acts toincrease the output voltage of the electrical signal before sending theelectrical signal to output 808.

FIG. 20 is a block diagram of another exemplary electrical schematic forcontroller 102. In this embodiment, controller 102 is formed fromprimarily digital circuitry. Controller 102 includes power supply 902,battery 904, controller processor 906, power switch 108, amplitudeadjustment switches 910, data communication device 912, data storagedevice 914, output stage 916, and output 918. Controller 102 isconnected to external power source 920, to charge battery 904. In oneembodiment, external power source 920 is a home or commercial powersupply, such as available through an electrical power outlet. In anotherembodiment, external power source 920 is an vehicle power supply, suchas accessible through a 12V receptacle.

During normal operation, power supply 902 receives power from battery904. Power supply 902 converts the battery power to a desired voltagebefore supplying the power to other components of controller 102. Powersupply 902 also includes battery charger 930. Battery charger 930receives power from an external power supply and operates to rechargebattery 904.

Control processor 906 controls the operation of controller 102. Controlprocessor 906 is powered by power supply 902. Control processor 906 alsogenerates electrical signals that are provided to output stage 916.

Control processor 906 is electrically coupled to power switch 908 andamplitude adjustment switches 910. Control processor 906 monitors thestate of power switch 908. When control processor 906 detects that thestate of power switch 908 has changed, control processor 906 turnscontroller 102 ON or OFF accordingly. Control processor 906 alsomonitors the state of amplitude adjustment switches 910. When controlprocessor 906 detects that the state of amplitude adjustment switches910 has changed, control processor 906 increases or decreases theintensity of electrical signals provided to output stage 916accordingly.

Control processor 906 includes memory 932. Firmware 934 is stored inmemory 932. Firmware 934 includes software commands and algorithms thatare executed by control processor 906 and defines logical operationsperformed by control processor 906. The software commands and algorithmsin firmware 932 may be used to operate the electrical stimulation devicein a desired mode, such as a mode that provides transcutaneouselectrical nerve stimulation therapy. In certain embodiments, controller102 includes a data communication device 912. Data communication devicesinclude wired or wireless communication devices, such as serial buscommunication devices (e.g., a Universal Serial Bus communicationdevices), local area networking communication devices (e.g., an Ethernetcommunication device), a modem, a wireless area networking communicationdevice (e.g., an 802.11x communication device), a wireless personal areanetworking device (e.g., a Bluetooth™ communication device or othercommunication device.

Data communication device 912 can be used to send and receive data withanother device. For example, data communication device 912 can be usedto download different firmware 934 to the controller 102 to alter theoperation of control processor 906, and operate the therapeuticelectrical stimulation device in a desired mode, such as a mode thatprovides iontophoresis therapy. In certain embodiments, a firmwarealgorithm must be purchased before it can be downloaded by a user. Incertain embodiments, the a user must access a patient interface of a webserver or other similar interface before downloading a firmwarealgorithm. Data communication device 912 can also be used to upload datato another device. For example, control processor 906 stores a therapylog in data storage device 914. The control processor 906 can be used toupload the therapy log to an external device by sending the data log todata communication device 912.

Data storage device is a device capable of storing data, such as amemory card or other known data storage device. In some embodiments,data storage device 914 is part of memory 932.

When controller 102 is ON, control processor 906 generates therapeuticelectrical signals, and provides those signals to output stage 916.Output stage 916 converts and filters the electrical signals, and thenprovides the electrical signals to output 918. Output 918 iselectrically coupled to a patch that delivers electrical signals to thepatient.

FIG. 21 is an electrical schematic of another exemplary circuit forcontroller 102. In this embodiment, controller 102 includes a controlprocessor 1006 that controls the operation of controller 102. In thisembodiment, controller 102 is made from primarily digital circuitry.Controller 102 includes power supply 1002, battery 1004, controlprocessor 1006, power switch 1008, amplitude adjustment switches 1010,output stage 1016, and output 1018. Controller 102 can also be connectedto external power source 1020, such as to charge battery 1004.

In this embodiment, power supply 1002 includes a lithium-ion chargemanagement controller 1030 and a step up converter 1032, as well asother electrical components as shown. An example of a suitablelithium-ion charge management controller 1030 is the MCP73833stand-alone linear lithium-ion charge management controller manufacturedby Microchip Technology Inc., of Chandler, Ariz. An example of asuitable step up converter is the LTC3401 micropower synchronous boostconverter.

Battery 1004 provides power to power supply 1002. In this example,battery 1004 is a lithium-ion 3.7V battery. Power supply 1002 can alsobe connected to external power source 1020, such as a 5V DC powersource. External power source 1020 provides power to power supply 1002that enables power supply 1002 to recharge battery 1004. In someembodiments, battery 1004 includes a thermistor to monitor thetemperature of battery 1004 during charging.

Control processor 1006 controls the operation of controller 102. Oneexample of a suitable control processor 1006 is the ATtiny44 8-bitmicrocontroller manufactured by Amtel Corporation, located in San Jose,Calif. Alternatively, various other processing devices may also be usedincluding other microprocessors, central processing units (CPUs),microcontrollers, programmable logic devices, field programmable gatearrays, digital signal processing (DSP) devices, and the like. Controlprocessor 1006 may be of any general variety such as reduced instructionset computing (RISC) devices, complex instruction set computing devices(CISC), or specially designed processing devices such as anapplication-specific integrated circuit (ASIC) device.

Control processor 1006 is electrically coupled to power switch 1008 andamplitude adjustment switches 1010. Power switch 1008 provides signalsto control processor 1006 that cause control processor 1006 to alternatecontroller 102 between ON and OFF states accordingly. Amplitudeadjustment switches 1010 instruct control processor 1006 to adjust theintensity of the electrical signals generated by controller 102.Electrical signals generated by control processor 1006 are passed tooutput stage 1016.

Output stage 1016 converts the electrical signals received from controlprocessor 1006 to an appropriate form and then provides the electricalsignals to output 1018. In this example, output stage 1016 includesMOSFET 1042 and transformer 1044. Other embodiments do not includetransformer 1044, but rather use a flyback converter or other converterto generate an appropriate output signal.

FIG. 22 is a top perspective view of another exemplary embodiment ofpatch 104. Patch 104 includes insulating layer 212 and shoe 120. Shoe120 is connected to a surface of insulating layer 212. In thisembodiment, shoe 120 includes wires 1101 and 1103 that are electricallycoupled to conductors within shoe 120. The wires 1101 and 1103 may beconnected to conductors within shoe 120 using a metal crimp or othersuitable method of electrical connection. Wires 1101 and 1103 are alsoconnected at an opposite end to patches 1102 and 1104. Patches 1102 and1104 may include electrodes such as a conducting polymer material. Patch104 may be used in a garment or medical device such as the belt depictedin FIGS. 23 A-D.

In one embodiment, patch 104 includes one or more electrodes, such asshown in FIG. 13, and an adhesive layer that allows patch 104 to beconnected to a patient or other device. In another embodiment, patch 104does not include an electrode, but rather passes electrical signalsthrough wires 1101 and 1103 to separate patches 1102 and 1104. Patches1102 and 1104 include an insulating layer and one or more electrodes,but do not include a shoe. Instead, patches 1102 and 1104 receiveelectrical signals from the shoe included in patch 104. Patches 1102 and1104 can be adhered to the patient such as with an adhesive layer. Theelectrodes of patches 1102 and 1104 direct the electrical signals todesired therapeutic locations of the patient.

Other embodiments include any number of wires 1101 and 1103 and anynumber of patches 1102 and 1104 (e.g., one patch, two patches, threepatches, four patches, five patches, etc.) as desired for a particulartherapy. Shoe 120 includes an appropriate number of electricalconductors that can provide multiple electrical conduction channels forcommunicating electrical signals between controller 102 (such as shownin FIG. 12) and the patches. In some embodiments, wires 1101 and 1103are formed adjacent to or within insulating layers to provide additionalprotection to the wires from damage. In some embodiments, wires 1101 and1103 are other types of electrical conductors. In other examples,multiple electrode sites can be positioned in a patch 104. For example,a quad-patch can be formed with an insulating layer having four lobes,with each lobe having an electrode for delivery of therapy, as describedbelow with respect to FIG. 23D. Other configurations are possible.

In some embodiments, patches 104, 1102, and 1104 are held in place by aband, strap, brace, built, garment, active wear, or other suitablesupporting object. For example, patches can be formed integral with asupporting object or inserted within a pocket or recess of a supportingobject. Some embodiments include integrated hot or cold packs. Theconnection to a supporting object may be made by stitching, gluing,snapping, velcroing, embedding in a laminate layer or any other possibleway to connect one or more of elements 1101, 1103, 104, 1102 and 1104 toa supporting material. In embodiments where one or more of elements1101, 1103, 104, 1102 and 1104 are formed integral with a supportingobject, they may be washed or cleaned (e.g., in a washing machine, soapand water, dry cleaned, etc.) along with the supporting object. Somefurther examples are illustrated in FIG. 23A.

FIG. 23A schematically illustrates some of the possible applications andconfigurations of therapeutic electrical stimulation device 100. FIG.23A illustrates a patient 1200 including a front profile (left) and arear profile (right).

One application of device 100 is to reduce joint pain or to reduceswelling in a joint. For example, device 100 is integrated into elbowbrace 1202, hip support 1204, knee braces 1206 and 1208, shoulder brace1210, glove 1212, back support 1214, and sock 1216 to provide relieffrom pain or swelling at the respective location. This illustrates thatdevice 100 can be used to treat symptoms at the patient's elbow, hip,knee, shoulder, wrist, hand, fingers, back, ankle, foot, or any otherjoint in the body.

Alternatively, embodiments of device 100 are directly adhered to thedesired therapeutic location, such as shoulder 1220, as describedherein.

Another application of device 100 is to reduce muscle or other tissuepain at any desired therapeutic location on the body. For example,device 100 is adhered to thigh 1222 of patient 1200.

Another application of device 100 is to stimulate wound healing. Forexample, device 100 can be placed on or adjacent to wound 1224 (shown onthe rear left thigh of patient 1200). Some embodiments of device 100 actas electronic adhesive bandage to promote wound healing and reduce painassociated with wound 1224. Some embodiments of device 100 includecontroller 102 and patch 104 (such as shown in FIG. 12) as a singlenon-separable unit.

Furthermore, alternate patch configurations (such as shown in FIG. 22)can be used to supply therapeutic electrical signals to multiplelocations of the body (e.g., a back and hip) or to multiple regions ofthe same body part (e.g., opposite sides of the knee or top and bottomof the foot).

FIGS. 23B and 23C show an example of how a therapeutic stimulationdevice, such as device 100, may be configured to provide therapy to asuser (e.g., as depicted in FIG. 23A). In FIG. 23B, shoe 13 is attachedto a garment 2602. The shoe 13 may be attached to garment 2062 in avariety of ways, for example it may be stitched or glued to the garmentor embedded in a laminate layer.

The garment 2062 may be any type of garment or medical device such asclothing or elbow brace 1202, hip support 1204, knee braces 1206 and1208, shoulder brace 1210, glove 1212, back support 1214, and sock 1216.The garment 2602 is connected to one or more electrodes 1502 positionedadjacent the garment and electrically connected to lead wire 46. One ormore electrodes 1502 may be placed in various positions on the garment2602 (e.g., the layout shown in FIG. 23D). The electrodes 1502 may bewired and connected electrically in various patterns and orders and toone or more different shoes 13. For example, two of the electrodes 1502(right) of FIG. 23D are electrically connected to each other but not tothe electrodes 1502 (left). The variance in electrode patterns andelectrical connections allows for the ability to create variousstimulation schemes for therapy. The electrodes are made of a conductivepolymer, stainless steel or other suitable material, and may beintegrated within the garment or connected to the outside of the garmentby sewing, gluing, velcroing or other suitable attachment schemes.

In certain embodiments, stainless steel snaps (male connector) arestamped through the garment and are thereby securely connected to thegarment. The snaps are electrically conductive and allow for anelectrode (female connector) to mechanically and electrically connect tothe male snaps and become secured to the garment. The male snaps areconnected to leads wires 46 and 48, which are electrically connected tothe shoe 13. Snap connectors for electrodes are described in more detailin U.S. Pat. No. 6,438,428 which is incorporated herein by reference.

As shown in FIGS. 23B and 23C, the base 44 of shoe 13 and one or more ofthe lead wires 46 are positioned between layers of the garment 2602.This allows the wires 46 to be hidden and shielded from the user. Thebase 44 physically holds the shoe 13 within the garment to create aconnection between the garment and the shoe. The top of shoe 13 isexposed on the outside of garment 2602, to allow connection tocontroller 11. In certain embodiments, shoe 13, lead wires 46, andelectrode 1502 remain attached as a unit, while the controller 11 may befrequently detached and reused for other applications with other shoesor at a different times with the same shoe. In this example, the shoe13, lead wires 46, and electrode 1502 elements may all be washed orcleaned together. Typically, the garment including the shoe, wire, andelectrodes are used for about 6 months before being disposed andreplaced.

In certain embodiments, the electrode 1502 connects directly to a user1506 by sitting directly on top of the skin. In other embodiments, anadhesive layer 1504 is affixed to electrode 1502 and the adhesive layeraffixes the electrode to the patient. The adhesive layer 1504 is aconductor to allow current to pass from the electrode 1502 to thepatient 1506. The adhesive layer 1504 may be sticky on both sides sothat a more reliable electrical and mechanical connection is made withthe skin of a user. In certain embodiments only one side of the adhesivelayer 1504 is sticky, and one side (e.g., the exposed side) of theelectrode 1502 is sticky. Typically the adhesive layer 1504 is used onlyonce before being disposed, though it may be reused multiple times.

In some embodiments, multiple devices 100 are in data communication witheach other to synchronize therapies provided by each respective device.For example, wireless communication devices (e.g., 912 shown in FIG. 20)are used to communicate between two or more devices 100.

In some embodiments, device 100 is configured to provide interferentialtherapy, such as to treat pain originating within tissues deeper withinthe body than a typical TENS device.

Some embodiments of device 100 are configured for drug delivery. Suchembodiments typically include a drug reservoir (such as absorbent pads)within patch 104 (e.g., shown in FIG. 13). Iontophoresis is then used topropel the drug (such as medication or bioactive-agents) transdermallyby repulsive electromotive forces generated by controller 102. Anexample of a suitable device for iontophoresis is described in U.S. Pat.No. 6,167,302 by Philippe Millot, titled DEVICE FOR TRANSCUTANEOUSADMINISTRATION OF MEDICATIONS USING IONTOPHORESIS, the disclosure ofwhich is hereby incorporated by reference in its entirety.

Other therapies can also be delivered. For example, controller 100 canbe programmed to deliver microcurrent. Such microcurrent can be aconstant voltage that is delivered for wound healing purposes. Othertherapies can be delivered to address pain, edema, drop-foot, and otherabnormalities.

The components of the therapeutic electrical stimulation devices, suchas device 10 and garment 2602, are manufactured to be disposable andreplaced after the useful life of such components has expired. Usefullife of a component can be defined, for example, by number of uses ofthe particular component, the lifetime of a component before wearingout, time established by the manufacturer, time available betweenreimbursements by Medicare or Medicaid (or other similar programs), orother similar standards. In certain embodiments, the controller isprovided with a manufacturer-imposed useful life of about 5 years, suchthat upon the expiration of such 5 years, a replacement controller ismade available to the patient. During its useful life, the controllermay be reused for multiple applications on various different garmentsand with several different shoes 13. In certain embodiments, thegarment, such as shown in FIG. 23A-D, including shoe 13 and patch 104,is provided with a manufacturer imposed useful life of about 6 months orless. In certain embodiments, the adhesive layer (e.g. adhesive layer128) is provided with manufacturer imposed useful life of oneapplication or use, though it may be reused multiple times. In certainembodiments, a user uses a certain number of adhesives (e.g., a packageof 10) on a monthly basis.

In certain embodiments, the useful life of the component ispredetermined prior to initial use or sale of the component, and it isreplaced upon expiration of the useful life. In some implementations,the predetermined useful life coincides with a period established byregulatory or other administrative authority by paying for orreimbursing for such component. In some embodiments, such predetermineduseful life is shorter than the period in which the component becomesphysically worn out or inoperable.

FIG. 24 is a perspective view of an exemplary docking station 1300.Docking station 1300 includes housing 1302 including multiple slots1304, 1306, and 1308 and status indicators 1310 associated with eachslot.

Each slot of the docking station 1300 is arranged and configured toreceive a controller 102 of a therapeutic electrical stimulation device100, such that multiple controllers 102 can be connected with dockingstation 1300 at any time. However, some embodiments of docking station1300 include only a single slot 1304 or other port for connection to asingle controller 102. Other embodiments include any number of slots asdesired.

Docking station 1300 includes an electrical connector similar toconnector 51 in shoe 13, such as shown in FIGS. 8A and 8B. When device100 is inserted into docking station 1300, shoe 120 engages withreceptacle 211, such as described with respect to FIGS. 14-16. When theshoe 120 engages with receptacle 211, pins 31 a-31 c combine withreceptacle 211 to form an electrical connection. When device 100 iscoupled with docking station 1300, data is transferred through pin 31 ato the docking station 1300 through an abutting connector wire insidethe station 1300, similar to the connection formed when pin 31 a joinswire 46, as shown in FIG. 10B. A ground connection is similarly madethrough pin 31 b, and the battery in controller 102 is charged throughpin 31 c.

In this example, docking station 1300 performs two primary functions.The first function of docking station 1300 is to recharge the battery ofcontroller 102. To do so, docking station 1300 is typically electricallycoupled to a power source such as an electrical wall outlet. Dockingstation 1300 converts the power from the electrical wall outlet to anappropriate form and then provides the power to the power supply (e.g.,902 shown in FIG. 20) of controller 102.

The second function of docking station 1300 is to communicate databetween controller 102 and a communication network. Controller 102 cansend data to docking station 1300 and can receive data from dockingstation 1300. This function is described in more detail with referenceto FIG. 25.

Some embodiments of docking station 1300 provide only one of thesefunctions. Other embodiments provide additional features andfunctionality. For example, some embodiments of docking station 1300allow multiple devices 100 to communicate with each other when connectedwith docking station 1300. In other examples, docking station 1300 isalso configured to communicate with one or more computers accessiblethrough a network, as described below. This allows for interactive datasharing between devices in order to promote, for example, greaterefficiency in hospitals. Connection to the docking station 1300 allowsnurses to keep a record of pain management for patients, and therebyincrease the quality of care.

Docking station 1300 includes status indicators 1310 associated witheach slot of docking station 1300. In this example, status indicators1310 include a data communication indicator and a charging indicator.The data communication indicator is a light emitting diode (LED) thatilluminates when the docking station 1300 is communicating with therespective controller 102. The charging indicator is an LED thatilluminates when docking station 1300 is charging the respectivecontroller 102. Other embodiments include additional status indicators1310. Other types of status indicators include audible status indicators(e.g., speakers, buzzers, alarms, and the like) and visible statusindicators (e.g., lights, liquid crystal displays, display screens, andthe like).

Docking station 1300 is not limited to connection with a single type ofcontroller 102. Multiple types of controllers 102 can be connected withdocking station 1300 at any one time, if desired. For example,controllers 102 include a TENS device, an iontophoresis device, a musclestimulation device (e.g., a neuromuscular electrical stimulation (NMES)device), a wound healing device, an interferential device, or otherdevices.

In some examples, docking station 1300 is configured to be used at apatient's home, such as in a bathroom or kitchen. Docking station 1300can include multiple stations for charging different types of devices,as well as drawers and other conveniences that allow docking station1300 to be used for multiple purposes.

FIG. 25 is a block diagram of an exemplary system for communicatingacross communication network 1400 involving therapeutic electricalstimulation devices. The system includes devices 102, 1402, and 1404.Devices 102 are in data communication with docking station 1300, such asshown in FIG. 24. Device 1402 includes a wireless communication deviceand device 1404 includes a wired network communication device. Thesystem also includes server 1406, caregiver computing system 1408, andpatient computing system 1410. Server 1406 includes database 1412 andWeb server 1414. System also includes wireless router 1416.

Communication network 1400 is a data communication network thatcommunicates data signals between devices. In this example,communication network 1400 is in data communication with docking station1300, device 1402, device 1404, server 1406, caregiver computing system1408, patient computing system 1410, and wireless router 1416. Dockingstation 1300 is in data communication with devices 102. Wireless router1416 is in data communication with device 1404. Examples ofcommunication network 1400 include the Internet, a local area network,an intranet, and other communication networks.

In some embodiments, devices 102, 1402, and 1404 store, in memory, datarelating to therapy delivery or other operational characteristics of therespective devices. Communication network 1400 can be used tocommunicate that data to another device. For example, the data istransferred to patient computing system 1410 or to caregiver computingsystem 1408. Once the data has been transferred to the computing system,the data is stored for review and analysis by the patient or thecaregiver. Communication network 1400 can also be used to communicatedata from devices 102, 1402, and 1404 to server 1406. Server 1406 storesthe data in patient record 1420.

In some embodiments, server 1406 includes Web server 1414. Web server1414 includes caregiver interface 1430 patient interface 1432.Additional interfaces are provided in some embodiments to third parties,such as an insurance company. Web server 1414 generates web pages thatare communicated across communication network 1400 using a standardcommunication protocol. An example of such a protocol is hypertexttransfer protocol. The webpage data is arranged in a standard form, suchas hypertext markup language. Thew data is transferred acrosscommunication network 1400 and received by computing system 1408 andcomputing system 1410. A browser operating on respective computingsystem reads the webpage data and displays the webpage to the user.

Caregiver interface 1430 generates a webpage intended for use by acaregiver. The caregiver interface 1430 allows the caregiver to accesspatient records 1420 and generates reports or graphs to assist thecaregiver in analyzing data from patient records 1420. In addition,caregiver interface 1430 provides technical or medical suggestions tothe caregiver. In some embodiments, caregiver interface 1430 also allowsthe caregiver to request adjustments to an operational mode of a device102, 1402, or 1404. The operational mode adjustments are thencommunicated from server 1406 to the device, and the device makes theappropriate mode adjustments.

Patient interface 1432 generates a webpage intended for use by apatient. In one example, patient interface 1432 allows the patient toaccess patient records 1420 and generates reports or graphs that assistthe patient in analyzing data from patient records 1420. Patientinterface 1432 provides instructions to assist the patient withuploading data from device 102, 1402, or 1404 to patient records 1420.Instructions or other educational information is also provided bypatient interface 1432, if desired.

In some embodiments, database 1412 includes firmware repository 1422.Firmware repository 1422 includes data instructions that define thelogical operation of a controller 102 (e.g. firmware 934 shown in FIG.20). Firmware repository 1422 is used in some embodiments to storevarious versions of firmware. For example, when a new firmware versionis created, the developer stores the new version of firmware in thefirmware repository 1422. The firmware is then communicated to theappropriate devices 102, 1402, or 1404. The communication of newfirmware versions can be either automatically distributed, or providedas an option to a patient or caregiver through interfaces 1430 and 1432.In some embodiments, patient interface 1432 requires that a patientagree to pay for an upgraded firmware version before the firmware ismade available for installation on a device.

In another embodiment, firmware repository 1422 includes differentfirmware algorithms. Each firmware algorithm is specifically tailored toprovide a specific therapy when executed by devices 102, 1402, 1404 orto be used with a particular hardware configuration. Examples oftherapies defined by separate firmware algorithms include TENS,interferential therapy, edema therapy, muscle stimulation, iontophoresistherapy, and other therapies. A different firmware algorithm can also bespecifically tailored for particular hardware configurations, such asfor particular electrode numbers or configurations, for particular datacommunication devices, for different docking stations, or to accommodateother differences in hardware configuration.

For example, a patient may first obtain a TENS device including a patchshown in FIG. 12. The device includes a first firmware type that definesan algorithm appropriate for TENS therapy. Later, the patient desires toupgrade the device to cause the device to operate as an iontophoresisdevice. To do so, the patient uses patient computing system 1410 toaccess patient interface 1432. The patient selects a new firmwarealgorithm that is designed for iontophoresis therapy. The patientpurchases and downloads the firmware associated with the iontophoresistherapy and loads the firmware onto the device. If necessary, anappropriate patch can be purchased through patient interface 1432 anddelivered to the patient. The patch is then connected to the devicecontroller and the new firmware algorithm is executed. The firmwarecauses the device to provide the desired iontophoresis therapy. In thisway, some embodiments of controller 102 are customizable to providemultiple different therapies.

In another embodiment, firmware is specially tailored for providing atherapy to a particular part of the body. As a result, separate firmwarealgorithms are available for the treatment of separate body parts andconditions associated with those body parts. Such firmware algorithmscan be obtained by downloaded, as described above.

In some embodiments, controllers 11, 100 include graphical userinterfaces that allow the user to control the controllers 11, 100 andthe therapy provided thereby. For example, the controllers can includebuilt-in displays that are used to present the user interfaces. The userinterfaces have home pages that allow the user to control variousaspects of the controller, such as turning the device on and off, thetype of therapy provided, and the intensity of the therapy.

In other examples, a separate device is used to control the controllers11, 100. This device can communicate with the controllers 11, 100through wired or wireless means (e.g., Wifi, Bluetooth). For example, adocking station (e.g., docking station 1300 described above) can includea user interface that is programmed to control the therapy provided bycontrollers 11, 100. The docking station can communicate wirelessly withcontrollers 11, 100.

In some examples, controllers 11, 100 can include additionalfunctionality, such as open lead detection. If a lead looses contactwith a surface that is being delivered therapy, controllers 11, 100 areprogrammed to detect the open lead and to modify therapy appropriatelyuntil the lead again makes contact. For example, controllers 11, 100 canbe programmed to shut down therapy that is delivered to the open leadand to issue an alarm so that the user can replace the lead.

In other examples, controllers 11, 100 are programmed to sense feedbackfrom the user and modify therapy accordingly. For example, controllers11, 100 can be programmed to sense electromyographic biofeedback basedon muscle activity and regulate therapy accordingly. In other examples,controllers 11, 100 are programmed to sense impedance and delivertherapy accordingly. In other examples, other biofeedback such as heartrate or activity levels can also be monitored. Other configurations arepossible.

In some examples, the user can provide specific feedback as well. Forexample, the user can set pain thresholds that controllers 11, 100 areprogrammed to remember. In other examples, the pain thresholds can beset automatically by controllers 11, 100 by monitoring capacitancelevels.

In yet other examples, controllers 11, 100 can include accelerometersand/or gyroscopes that can be used to measure orientation and activitylevel of the patient. For example, therapy can be adjusted based on theorientation of the patient (e.g., lying down or upright), as well asactivity level. Controllers 11, 100 can be programmed to adjust therapyover a specific time. In yet other examples, multiple controllers can beused, and the controllers can be programmed to communicate with eachother to synchronize the therapy that is delivered to the user, therebyforming a body area network. This network can be formed through wirelesscommunication and/or conductive communication through the patient'sbody.

The number of delivery channels can be modified (e.g., 2 channel vs. 4channel) to modify the type and intensity of therapy. Also, devices canbe connected in series to deliver an increase in therapy intensity orincrease the area treated.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the claimsattached hereto. Those skilled in the art will readily recognize variousmodifications and changes that may be made without following the exampleembodiments and applications illustrated and described herein, andwithout departing from the true spirit and scope of the disclosure.

What is claimed is:
 1. A system for delivering therapeutic electricalstimulation comprising: a patient interface component, a controllercomponent, and an intermediate component positioned between the patientinterface component and the controller component, wherein theintermediate component has conducting lines that provide electricalcommunication between a patient and the controller component, whereineach component has a useful life, and wherein the patient interfacecomponent has a useful life less than the intermediate component, andthe intermediate component has a useful life less than the controllercomponent.
 2. The system of claim 1, further comprising a garment thatcarries the components and is adapted to position the patient interfacecomponent against the patient.
 3. The system of claim 2, wherein theintermediate component is washable and reusable within its useful life.4. The system of claim 3, wherein the patient interface component is asingle-use adhesive.
 5. The system of claim 1 wherein the intermediatecomponent connects to the controller component by a mechanicalconnection.
 6. The system of claim 1 wherein the intermediate componentconnects to the controller component by an electrical connection.
 7. Thesystem of claim 1, wherein the controller component includes a powersource and an electrical signal generator powered by the power source.8. The system of claim 1, wherein the controller component includes arechargeable battery.
 9. The system of claim 7, wherein the controllercomponent includes a receptacle that contains at least one conductor,the conductor being electrically coupled to the electrical signalgenerator to receive an electrical signal, and the receptacle beingconfigured to receive a portion of the intermediate component toelectrically couple a portion of the intermediate component with theconductor.
 10. The system of claim 9, wherein the receptacle includes adetent positioned to matingly engage with the intermediate component andretain the intermediate component within the receptacle.
 11. The systemof claim 10, comprising a patch for a therapeutic electrical stimulationdevice, the patch comprising a shoe connected to at least one insulatinglayer and including at least one conductor, wherein the shoe isconfigured for insertion into the receptacle of the controllercomponent.
 12. The system of claim 11, wherein the patch includes atleast one electrode electrically coupled to the at least one conductor.13. The system of claim 11, wherein the patch comprises an electricalinter connection surface and a mechanical interconnection surface,wherein the electrical inter connection surface and the mechanicalinterconnection surface extend in directions substantially parallel toeach other.
 14. The system of claim 11, wherein the patch is carried ina disposable garment configured to be worn by a user.
 15. The system ofclaim 11, wherein an adhesive layer is connected to the at least oneelectrode.
 16. The system of claim 1, wherein the interface component isa conductor material, the conductor material being connected to theintermediate component.
 17. The system of claim 16, wherein at least oneside of the conductor includes an adhesive.
 18. The system of claim 1,wherein the controller component has a useful life of about 5 years. 19.The system of claim 18, wherein the intermediate component has a usefullife of about 6 months or less.
 20. The system of claim 19, wherein theinterface component has a useful life of approximately one use.